Benzonatate

Product NDC
55154-3372
11-digit product format
551543372
Labeler code
55154
Product ID
55154-3372_6d335622-6974-451b-8a27-126a62d02abc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA206948
Marketing category
ANDA
Marketing start
2018-12-21
Substance
BENZONATATE
Active strength
100 mg/1
Pharmacologic classes
Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Benzonatate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZONATATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5P4DHS6ENR
Rxcui197397

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc429dc2-e942-6686-8d72-b63c57e806aaProduct name520190416
d45c2ed6-126c-dd22-afd2-e29a2ecf77b9Product name320190215

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-3372-0Benzonatate10 in 1 BAGCAPSULE105
55154-3372-0Benzonatate1 in 1 BLISTER PACKCAPSULE15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-3372BENZONATATE CAPSULE [CARDINAL HEALTH 107, LLC]3Current NDC, 2 package rows20241109_b46f231a-65d3-400d-ae6b-3216830807a2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSNb46f231a-65d3-400d-ae6b-3216830807a25
197397benzonatate 100 MG Oral CapsuleSCDb46f231a-65d3-400d-ae6b-3216830807a25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55154-3372-05515433720010 BLISTER PACK in 1 BAG (55154-3372-0) / 1 CAPSULE in 1 BLISTER PACK10 blister pack2018-12-21NoNoHistorical